(126 days)
Not Found
No
The device description and intended use clearly define a synthetic bone graft material with no mention of software, algorithms, or any technology that would incorporate AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
Yes
The device is a bone grafting material used to fill, augment or reconstruct defects, which is a therapeutic intervention.
No
The device is a bone grafting material for filling, augmenting, or reconstructing defects, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a synthetic osteoconductive bone graft substitute composed of physical materials (hydroxyapatite and beta-tricalcium phosphate) and is supplied as irregular shaped particles. This indicates a physical medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to fill, augment, or reconstruct bone defects in the body. This is a therapeutic or reconstructive purpose, not a diagnostic one.
- Device Description: The device is a synthetic bone graft substitute. It is a material implanted into the body.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples from the body (like blood, urine, or tissue) to diagnose a condition or provide information about a patient's health status.
IVD devices are used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used in vivo (inside the body) for a therapeutic purpose.
N/A
Intended Use / Indications for Use
OSTEON, OSTEON Sinus, OSTEON Lifting are intended for use as a bone grafting material to fill, augment or reconstruct periodontal or oral/maxillofacial defects.
- Periodontal/Infrabony defects
- Ridge augmentation
- Extraction sites (implant preparation/placement)
- Sinus lifts
- Cystic cavities
Product codes (comma separated list FDA assigned to the subject device)
LYC
Device Description
This product is a synthetic osteoconductive bone graft substitute composed of hydroxyapatite (HA) and beta-tricalcium phosphate (B-TCP). This product presents an interconnected porous structure, similar to that of human cancellous bone. This product is available as irregular shaped particles of size 0.3~2.0 mm. It is supplied sterile by gamma irradiation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
periodontal or oral/maxillofacial
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
OSTEON, OSTEON Sinus, OSTEON Lifting have been subjected to extensive safety, performance and product validations prior to release. Safety tests including shelf-life, sterilization validation have been performed to ensure the devices comply with applicable international and US regulations.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.3930 Bone grafting material.
(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
Image /page/0/Picture/0 description: The image shows the word "GENOSS" in bold, black letters. The letters are sans-serif and slightly slanted to the right. The word appears to be a logo or brand name. The background is plain white.
510(k) Summary
NOV 1 9 2010
07/08/2010
ﮨﮯ
1. Company
.
| Submitter | |
|---|---|
| Name | Genoss Co., Ltd. |
| Address | 1F Gyeonggi R&DB Center, 906-5 Iui-dong, Suwon-si, Yeongtong-gu, |
| Gyeonggi-do, 433-270, Korea | |
| Phone/Fax | +82-31-888-5100/ +82-31-888-5105 |
| Contact person | Dahye Kim / QA |
| dhkim2@implantium.com |
2. Device Name
| Proprietary name: | OSTEON, OSTEON Sinus, OSTEON Lifting |
|---|---|
| Common name: | Bone grafting material |
| Classification name: | Bone grafting material, Synthetic |
3. Predicated Device
K062834 OSTEON
4. Description
This product is a synthetic osteoconductive bone graft substitute composed of hydroxyapatite (HA) and beta-tricalcium phosphate (B-TCP). This product presents an interconnected porous structure, similar to that of human cancellous bone. This product is available as irregular shaped particles of size 0.3~2.0 mm. It is supplied sterile by gamma irradiation.
510(k) Summary
Page 1 of 2
1
GENOS
5. Indication for use
OSTEON, OSTEON Sinus, OSTEON Lifting are intended for use as a bone grafting material to fill, augment or reconstruct periodontal or oral/maxillofacial defects.
- Periodontal/Infrabony defects
- Ridge augmentation
- Extraction sites (implant preparation/placement)
- Sinus lifts
- Cystic cavities
6. Review
OSTEON, OSTEON Sinus, OSTEON Lifting have the similar technological characteristics as the predicate device; main material, indication for use and design.
OSTEON, OSTEON Sinus, OSTEON Lifting have been subjected to extensive safety, performance and product validations prior to release. Safety tests including shelf-life, sterilization validation have been performed to ensure the devices comply with applicable international and US regulations.
7. Conclusion
Based on the information provided in this premarket notification of Genoss Co., Ltd. concludes that the five years shelf-life of OSTEON, OSTEON Sinus, OSTEON Lifting are acceptable and safe, substantially equivalent to predicate devices
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with lines suggesting movement or connection between them.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Genocc Company, Limited C/O Dr. Eunkyung Son Dentium USA l 1075 Knott Avenue, Suite A Cypress, California 90630
NOV 1 9 2010
Re: K102015
Trade/Device Name: OSTEON, OSTEON Sinus, OSTEON Lifting
Regulation Number: 21 CER 872 2020 Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: LYC Dated: October 21, 2010 Received: October 21, 2010
Dear Dr. Son:
We have reviewed your Section 510(k) premarket notification of intent to market the device is referenced above and have determined the device is substantially equivalent to market the indications for use stated in the enclosure) to legally market predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medicate devices mark.
Amendments, or to devices that have been reclessified Amenders, or to devices that have been reclassified in accordance with the Medical Device of the Medical Device of the Federal Food
the Federal Food, Drug, and Cosmetic Act ( the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of the Federal of
the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a approval application (PMA). You may, therefore, market the device, subject to factorial of a
controls provisions of the Act. The general controls provisions of the general controls provisions of the Act. The general controls provisions of the Act the devices to the entile
requirements for annual registration listing of devices requirements for alle rice. Tire general controls provisions of the Act and Active of the Active Station of the Active, labelir,
and probibitions against misbranding and adu and more of anian registration, ilsting of devices, good manufacturing practice, labeling,
and prohibitions against misbranding and adulteration. Please not evaluate information related to contract liability warranties. We remind you, however, we a
labeling must be truthful and not misleading labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject (School) into either class II (Special Controls) or class III
(PMA), it may be subject to additional controls. Existing major regulations affecting device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898.
addition, FDA may publish further announcements constitue 21, Parts 800 to 898. In addition, FDA may publish firther announcements concerning your device in the Federal
Register.
3
Page 2- Dr. Son
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA sisuance of a substantial equivalence determination does not
mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other requirement.
You must comply with all the Act's requirements including ther Federal agencies. You must comply with all the Act's requirements, including, but not limited to recoment.
You must comply with all the Act's requirements, including, but not limited to: regis and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device regist
and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing
(reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (2) and manufacturing
and if applicable, the electronic product radiation control on (21 CFR Part 82 and if applicable, the electronic product radiation control provision (21 crk resultation (21 CFR Park 2000)
and if applicable, the electronic product radiation control provi the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801),
please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm1115809.htm for the Center for Devices and Radiological Health's (CDRH) s) Office of Compliance. Also, him for and please note the regulation entitled, "Misbranding by reference to premarket notification".
(21CFR Part 807.97). For questions regarding the security of the ice and 10 regulation entined, "Misoranding by reference to premarket notification"
(21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/SafetyReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Salety/KeportalProblem/default.html for
Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at them the Act from the Act from the Act from the number (800) 638-2041 or (301) 796-7100 or at its Internet Assist
http://www.fda.gov/ModicolDo.i http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
source: /pd/industry/default.ht
Sincerely yours,
Wh for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental He Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indication for use
K102015 -K062834 510(k) Number: OSTEON, OSTEON Sinus, OSTEON Lifting Device Name: Indication for use: OSTEON, OSTEON Sinus, OSTEON Lifting are intended for use as a bone grafting material to fill, augment or reconstruct periodontal or oral/maxillofacial defects - Periodontal/Infrabony defects - Ridge augmentation - Extraction sites (implant preparation/placement) - Sinus lifts - Cystic cavities
Prescription Use _ く (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device E
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
KIN2015 510(k) Number: _______________________________________________________________________________________________________________________________________________________________
Statement of Indication for use
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